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Methylumbelliferyl phosphate) is cycled in and out of the SPR®. The conjugate enzyme catalyzes the hydrolysis of this substrate into

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a fluorescent product (4-Methylumbelliferone), the fluorescence of which is measured at 450 nm.

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At the end of the assay, the results are analyzed automatically by the instrument, which generates a test value for each sample. This

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value is compared to a set of stored standards (thresholds) and each result is interpreted (positive or negative).

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General Information

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The current classification of the genus

Listeria

includes six species that are non-spore-forming, short, motile, Gram positive rods.

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These organisms are catalase positive, oxidase negative, hydrolyze esculin and ferment glucose without gas production.

Listeria

can

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grow at wide temperature and pH ranges and can tolerate high concentrations of sodium chloride (1,2).

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Members of the genus

Listeria

are ubiquitous and certain species are pathogenic.

Listeria

have been isolated from various food

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products including dairy products, meats, vegetables and seafood, as well as from environmental samples taken, in particular, from

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food processing plants.

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In humans, listeriosis is usually associated with the species

L. monocytogenes

and may cause meningitis, septicemia, encephalitis, and

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abortions. Groups at greatest risk include pregnant women, neonates, immunocompromised patients and the elderly (3). Traditional

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methods for the detection of

Listeria monocytogenes

involve enrichment that includes several tedious and labor-intensive steps. In

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addition, current culture methods require lengthy incubation periods to achieve final results (4,5).

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Scope of method

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The VIDAS®

L. monocytogenes

Xpress (LMX) test was evaluated in the

Performance Tested Methods

program for the detection of

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Listeria monocytogenes

in smoked white fish, cooked shrimp, peanut butter, frozen spinach, deli ham, vanilla ice cream and processed

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cheese. The method was compared to the US Food and Drug Administration

Bacteriological Analytical Manual

(FDA BAM) and the

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US Department of Agriculture Food Safety and Inspection Service

Microbiology Laboratory Guidebook

(USDA-FSIS MLG), and the

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AOAC INTERNATIONAL

Official Method

993.12 reference culture procedures (4, 5, 6). The VIDAS LMX was also evaluated in

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the GovVal program for the detection of

Listeria monocytogenes

in ready to eat meats (liver paté, hot dogs, raw fermented sausage,

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sliced deli turkey and sliced deli ham) in comparison to the Health Canada, Health Products and Food Branch

Compendium of

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Analytical Methods

reference method (7).

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Methods and Materials

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Test Kit Information

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a)

Kit Name -

VIDAS®

L. monocytogenes

Xpress (LMX)

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b)

Catalog Number – Reference 30123

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PTM Certification Report